FDA (Devices) recall action 77739

Medtronic Navigation, Inc. recalled 8 products on 2017-08-30

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2017-08-30
Critical: 0
Units: 603

Why these products were recalled

The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

HighFDA (Devices)··2017-08-30
Medtronic AxiEM ENT Suction Kits Recalled for Verification Failure
Medtronic is recalling eight AxiEM ENT suction kits because the instruments fail mandatory pre-use verification tests.
Product
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used
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ModerateFDA (Devices)··2017-08-30
Medtronic Curved Suction 90 Recalled for Verification Failure
Medtronic is recalling 75 Curved Suction 90 ENT instruments because they fail required pre-use verification checks.
Product
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. Th
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HighFDA (Devices)··2017-08-30
Medtronic AxiEM ENT Suction Devices Recalled for Verification Failure
Medtronic is recalling 60 reusable ENT suction instruments because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The
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HighFDA (Devices)··2017-08-30
Medtronic ENT Navigation Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling six kits of ENT suction devices because they fail required pre-use verification checks.
Product
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc.,
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ModerateFDA (Devices)··2017-08-30
Medtronic ENT Instrument Set Recalled for Verification Failure
Medtronic is recalling 13 reusable ENT instrument sets because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The sucti
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HighFDA (Devices)··2017-08-30
Medtronic Curved Suction 70 Recalled for Verification Failure
Medtronic is recalling 149 Curved Suction 70 ENT instruments because they fail required pre-use verification checks.
Product
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The
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HighFDA (Devices)··2017-08-30
Medtronic Fusion ENT Instrument Kit Recalled for Verification Failure
Medtronic is recalling 15 Fusion ENT Instrument Kits because the instruments fail pre-use verification. The kits were distributed in the US and Canada.
Product
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The su
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HighFDA (Devices)··2017-08-30
Medtronic ENT Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling 277 reusable ENT suction instruments because they fail pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The
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0 states